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Pin to quick picksGlaxosmithkline Share News (GSK)

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Share Price: 1,529.50
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Judge weighs key evidence ahead of first Zantac cancer trial

Thu, 16th Feb 2023 23:17

Feb 16 (Reuters) - Lawyers for a man who alleges he developed bladder cancer after taking GSK Plc's heartburn drug Zantac urged a California judge on Thursday to allow expert testimony linking the drug to the illness at an upcoming trial.

The trial in the case, brought by California resident James Goetz, is scheduled to begin Feb. 27 before Alameda County Superior Court Judge Evelio Grillo. It will offer the first test of how Zantac cancer claims may fare in state courts, and its outcome could depend heavily on what expert testimony Grillo allows.

A federal judge in December threw out all of the Zantac cases in federal court, some 50,000, after finding the opinions of the experts put forth by plaintiffs to establish their cancer was caused by the drug were not backed by sound science.

Tens of thousands of cases still remain in state courts, many consolidated before Grillo in California.

Brent Wisner, a lawyer for Goetz and other Zantac plaintiffs, argued that jurors should hear expert testimony about studies that he called "pretty powerful evidence that there is a causal relationship" between consuming Zantac's active ingredient, ranitidine, and cancer.

GSK has denied that the drug can cause cancer.

"Obviously our position is, no it doesn't," GSK lawyer Kimberly Branscome said at the hearing, which Reuters viewed via Courtroom View Network.

Zantac, first approved by the U.S. Food & Drug Administration in 1983, became the world's best selling medicine in 1988 and one of the first drugs to top $1 billion in annual sales.

Originally marketed by a forerunner of GSK, it was later sold successively to Pfizer Inc, Boehringer Ingelheim and finally Sanofi SA. All four drugmakers are facing Zantac lawsuits and have denied that the pill causes cancer.

In 2019, some manufacturers and pharmacies halted sales of the drug over concerns that its active ingredient, ranitidine, degraded over time to form a chemical called NDMA. While NDMA is found in low levels in food and water, it is known to cause cancer in larger amounts.

The FDA in 2020 pulled all remaining brand name Zantac and generic versions off the market, citing research showing the amount of NDMA in the products increases the longer the drug is stored and could potentially become unsafe.

Lawsuits began piling up soon after the recalls began from people who said they developed cancer after taking Zantac. Plaintiffs said the companies knew, or should have known, that ranitidine posed a cancer risk and that they failed to warn consumers.

Cases have been filed linking Zantac to at least 10 types of cancer. The now-dismissed federal litigation was limited to bladder, stomach, esophageal, liver and pancreatic cancers, but cases over other cancers remain in state courts. (Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi and Bill Berkrot)

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GSK cancer drug delay by FDA not "necessarily a red flag"

(Alliance News) - GSK PLC must gain approval for its "centrepiece" cancer drug momelotinib to validate its mergers & acquisitions pipeline but the extension of its review period in the US does not automatically spell trouble, according to analysis from Shore Capital on Friday.

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16 Jun 2023 07:47

FDA extends review period of GSK blood cancer drug momelotinib

(Sharecast News) - GSK said on Friday that the US Food and Drug Administration has extended the review period of its new drug application for momelotinib, which is used to treat a blood cancer called myelofibrosis.

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16 Jun 2023 07:42

IN BRIEF: GSK says FDA extending review period for blood cancer drug

GSK PLC - Brentford, England-based pharmaceutical company - Says US Food & Drug Administration has extended the review period of the new drug application for momelotinib by three months. Extension aims to provide time to review recently submitted data. The extended action date is September 16. Momelotinib uses "novel mechanism of action" to treat myelofibrosis, a rare blood cancer, as well as progressive anaemia which characterises the disease. Myelofibrosis affects approximately 25,000 US patients. The drug is not currently approved in any markets. GSK says it is "confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review."

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AstraZeneca hails RSV drug nirsevimab recommendation by FDA committee

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LONDON MARKET OPEN: Stocks head lower amid global growth fears

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TOP NEWS: GSK's Arexvy is first EU-approved RSV jab for older adults

(Alliance News) - GSK PLC on Wednesday announced that its RSV vaccine Arexvy has become the first EU-backed vaccine against the respiratory syncytial virus for adults aged 60 and older.

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GSK gets European approval for RSV vaccine

(Sharecast News) - Pharmaceuticals giant GSK announced on Wednesday that the European Commission has granted authorisation for 'Arexvy' - an adjuvant respiratory syncytial virus (RSV) vaccine - for active immunisation to prevent RSV-caused lower respiratory tract disease (LRTD) in adults 60 and older.

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US FDA accepts GSK's licence application for cancer treatment Jemperli

(Alliance News) - GSK PLC on Tuesday said the US Food & Drug Administration accepted its supplemental biologics licence application for endometrial cancer treatment dostarlimab, or Jemperli, after it was granted priority review in September.

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PRESS: Unilever starts search to replace Nils Andersen as chair

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US FDA accepts GSK supplemental application for Jemperli cancer drug

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US FDA approves Pfizer's RSV vaccine

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